Melagenina Plus - Vitiligo

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

Evaluation of the effectiveness and safety of melagenina plus in the treatment of patients with vitiligo. Phase IV.

Secondary indentifying numbers:

Not Applicable

Issuing authority of the secondary identifying numbers:

Not Applicable

Source(s) of monetary or material support:

Placental Histotherapy Center "Dr. Carlos Manuel Miyares Cao" (CHP)

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Trials notification

Regulatory instance:

Center for State Control of Drugs, Medical Devices and Equipment (CECMED)

Reference number:

In process

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Ernesto

Last name:

Miyares Diaz

Medical Specialty :

1st degree specialist in Dermatology

Affiliation:

Placental Histotherapy Center "Dr. Carlos Manuel Miyares Cao" (CHP)

Postal address:

18 Street # 4302, Miramar. Playa.

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72041757 ext. 114

+53-72552517 ext. 119

+53-72042524

+53-72047451

Email address:

ernesto@miyares-cao.cu [1]

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Havana, Hermanos Ameijeiras Hospital, Sonia E. Collazo Caballero, MD. 2nd Specialist Degree Dermatology

Havana, Calixto Garcia Hospital, Monica Alvarez Mesa,MD. Dermatology Specialist

Havana, Clinical Surgical Hospital October 10, Margarita Lopez Acosta, MD. Dermatology Specialist

Havana, Salvador Allende Hospital, Said Chaya Salgado, MD. Dermatology Specialist

Havana, Miguel Enriquez Hospital, Sixta M. Varela Villalobos, MD. Dermatology Specialist

Havana, Medical Surgical Research Center (CIMEQ), Aleida Urquiza Rodriguez, MD. Dermatology Specialist

Havana, Julio Trigo Hospital, Lorenzo Gonzalez Gonzalez, MD. Dermatology Specialist

Havana, Enrique Cabrera Hospital, Tamara Emilse Guerra Guerra, MD. Dermatology Specialist

Havana, Joaquin Albarran Hospital, Zenaida Gonzalez, MD. Dermatology Specialist

Havana, Manuel Fajardo Hospital, Olaine Gray Lovio, MD. Dermatology Specialist

Pinar del Rio, Leon Cuervo Rubio Hospital, Grecia Maria Giniebra Marin, MD. Dermatology Specialist

Matanzas, Comandante Faustino Perez Hospital, Cristy Darias Dominguez, MD. Dermatology Specialist

Villa Clara, Arnaldo Milian Castro Hospital, Leslie Suarez Becerra, MD. Dermatology Specialist

Sancti Spiritus, Camilo Cienfuegos Hospital, Yosjander Companioni Maya, MD. Dermatology Specialist

Ciego de Avila, Antonio Luaces Iraola Hospital, Odalis Perdomo Rosales, MD. Dermatology Specialist

Ciego de Avila, Roberto Rodriguez Hospital, Eridan Gonzalez Velazquez, MD. Dermatology Specialist

Camaguey, Manuel Ascunce Domenech Hospital, Teresa Diaz Renon, MD. Dermatology Specialist

Holguin, Lucia Iñiguez Hospital, Sonia Maria Peregrin Rodriguez, MD. Dermatology Specialist

Las Tunas, Ernesto Guevara Hospital, Erminda Ricardo Mora, MD. Dermatology Specialist

Granma, Bayamo, Carlos Manuel de Cespedes Hospital, Susel Rodriguez Ramirez, MD. Dermatology Specialist

Santiago de Cuba, Juan Bruno Zayas Hospital, Ana Lucia Jacas Portuond, MDo. Dermatology Specialist

Guantanamo, Agostinho Neto Hospital, Nivia Rojas Caraballo, MD. Dermatology Specialist

Havana, Angel Arturo Aballi Pediatric Hospital, Mirian Calixta Delgado Silv, MDa. Dermatology Specialist

Havana, La Balear Pediatric Hospital, Marila Gonzalez Gorrin, MD. Dermatology Specialist

Havana, William Soler Pediatric Hospital, Glenda Fernandez Ychaso, MD. Dermatology Specialist

Havana, Centro Habana Pediatric Hospital, Pilar Maria Acuña Aguilarte, MD. Dermatology Specialist

Havana, Juan Manuel Marquez Pediatric Hospital, Fernanda Pastrana Fundora, MD. Dermatology Specialist

Havana, Cerro Pediatric Hospital, Lidia Maryloli Torres Mariño, MD. Dermatology Specialist

Matanzas, Eliseo Noel Camacho Pediatric Hospital, Lisbeth Sabido Toled, MDo. Dermatology Specialist

Sancti Spiritus, Jose Marti Pediatric Hospital, .Glenda Montes de Oca Portal, MD. Dermatology Specialist

Camaguey, Eduardo Agramonte Pediatric Hospital, Maria I. Guerrero Fernandez, MD. Dermatology Specialist

Santiago de Cuba, Children's Hospital of the South, Teresina Samada Duran, MD. Dermatology Specialist

Research ethics committees:

Placental Histotherapy Center , 25/09/2018

Hermanos Amejeiras Hospital, 18/10/2018

Calixto Garcia Hospital , In review

10 de Octubre Hospital, In review

Salvador Allende Hospital, In review

Miguel Enriquez Hospital, 20/08/2018

CIMEQ Hospital, 16/08/2018

Julio Trigo Hospital, 12/10/2018

Enrique Cabrera Hospital, In review

Joaquin Albarran Hospital , 09/07/2018

Manuel Fajardo Hospital, 07/09/2018

Leon Cuervo Rubio Surgical Clinical Hospital, 05/10/2018

Faustino Perez Hospital, In review

Arnaldo Milian Castro Hospital, 04/07/2018

Camilo Cienfuegos Hospital, 19/07/2018

Antonio Luaces Hospital, 12/07/2018

Roberto Rodriguez Hospital, 17/07/2018

Manuel Ascunce Domenech Hospital, 18/07/2018

Lucia Iniguez Hospital, 12/07/2018

Ernesto Guevara Hospital, 30/07/2018

Carlos Manuel de Cespedes Hospital (GR-BY), 05/09/2018

Juan Bruno Zayas Hospital, 24/07/2018

Agostino Neto Hospital, In review

Angel Arturo Aballi Pediatric Hospital, 12/10/2018

La Balear Pediatric Hospital, In review

William Soler Pediatric Hospital , In review

Centro Habana Pediatric Hospital, In review

Juan Manuel Marquez Pediatric Hospital, In review

Cerro Pediatric Hospital, In review

Eliseo Noel Camacho Pediatric Hospital, In review

Jose Marti Pediatric Hospital, 17/08/2018

Eduardo Agramonte Provincial Pediatric Hospital, In review

Southern Children's Pediatric Hospital, 19/07/2018

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Pending

Date of first enrollment:

21/01/2019

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Vitiligo

Health condition(s) code:

Vitiligo

Hypopigmentation

Pigmentation Disorders

Skin Diseases

Skin and Connective Tissue Diseases

Skin Pigmentation

Intervention(s):

Group I Melagenina Plus® (Experimental): Melagenina Plus® by topical route every day, on a daily basis, with intervals of 24 hours, until completing 2 years.

Intervention code:

Placental Extracts

Dermatologic Agents

Intervention keyword:

Melagenina Plus, Lotion

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

Repigmentation of the affected area ( Using the Vitiligo area scoring index (VASI Questionnaire) and, the categories “Total repigmentation”, “Notable repigmentation”, “Partial repigmentation”, “Same”, “New injuries"). Measurement time: At baseline, 3, 6, 9, 12, 15, 18, 21 and, 24 months.

Key secondary outcomes:

1. Changes at the level of the spot (With changes, No Changes). Measurement time: At baseline, 3, 6, 9, 12, 15, 18, 21 and, 24 months. 2. Time to repigmentation (Time from the patient recruitment until repigmentation of 75% or more of the total area initially affected). Measurement time: At baseline, 3, 6, 9, 12, 15, 18, 21 and, 24 months. 3. Stabilization of the disease (Time from the patient reaches a repigmentation of 75% or more of the total area initially affected until that percentage decreases or new lesions appear. The maintenance of 80% of the repigmented lesions for 6 months or more will be considered treatment success). Measurement time: At baseline, 3, 6, 9, 12, 15, 18, 21 and, 24 months. 4. Quality of Life (Index of Quality of life measure by the Dermatology Life Quality Index-DLQI questionnaire). Measurement time: At baseline, 3, 6, 9, 12, 15, 18, 21 and, 24 months. 5. Adverse events-AE (Occurrence of adverse event (Yes, No), Description of the AE (Name of the AE), Duration of the AE (Date, time of begin and end of the AE, if the data is available), Intensity (Mild, Moderate, Severe), Seriousness (Serious, Not serious), Attitude towards the drug (changes, modification of the dose, temporary interruption, definitive interruption of the treatment), Result (recovered, improved, persists, left sequels), Causal relationship (very probable, probable, possible, unlikely, unrelated, non-assessable/unclassifiable)). Measurement time: 3, 6, 9, 12, 15, 18, 21 and, 24 months.

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Male/Female

Minimum age:

2 years

Maximum age:

60 years

Inclusion criteria:

1. Patients with a clinical and histological diagnosis of Vitiligo. 2. Patients of any sex and age between 2-60 years, inclusive. 3. Patients with depigmented areas between 1 and 40%. 4. Adult patients, mother, father or legal guardian who grant consent to participate in the study in writing. Patients between 2 and 11 years old (including both ages) who grant their consent to participate. Patients between 12 and 18 years old (including both ages) who give their informed consent together with the responsible adult.

Exclusion criteria:

1. Pregnant or lactating patients. 2. Patients with infectious disease associated with skin at the time of inclusion. 3. Patients with severe chronic disease requiring treatment with steroids. 4. Patients with psychiatric illnesses that could limit adherence to the requirements of the trial. 5. Patients with known immunosuppression history. 6. Patients who in 45 days prior to their assessment for inclusion in the study have received some treatment: immunopresors, topical or systemic corticosteroids, cyclosporine, UVA phototherapy or combined with psoralen, cytostatics. 7. Patients with oral or systemic contraceptive treatment. 8. Patients presenting chronic dermatitis with a depigmentary character or endocrine diseases that cause disorders in pigmentation (mainly Addison's disease, thyroid diseases and hypopitutarism).

Type of population:

Children/Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Single group

Phase:

Target sample size:

244

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Ivis

Last Name:

Mendoza Hernandez

Specialty:

Bachelor degree in Pharmaceutical Sciences. Master of Science in Pharmacology

Affiliation:

National Coordinator Center of Clinical Trials (CENCEC)

Postal Address:

5th street A between 60 and 62. Playa

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72164227

Email :

ivis@cencec.sld.cu [2]

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Ernest

Last Name:

Miyares Diaz

Specialty:

1st degree specialist in Dermatology

Affiliation:

Placental Histotherapy Center "Dr. Carlos Manuel Miyares Cao" (CHP)

Postal Address:

Placental Histotherapy Center “Dr. Carlos Manuel Miyares Cao". 18 Street # 4302, Miramar. Playa.

City:

Havana

País:

Cuba

Zip Code:

11300

Telephone:

+53-72041757, +53-72552517, +53-72042524, +53-72047451/52 ext. 114/119

Email :

ernesto@miyares-cao.cu [1]

About study completion

Section to complete the data related to the study completion.

Final enrolment number:

21/01/2021

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000297

Date of Registration in Primary Registry:

14/01/2019

Record Verification Date:

2020/12/21

Next update date:

2021/12/21

Link to the spanish version:

Click here [3]

Melagenina Plus - Vitiligo – phase IV